Device Recall ADVIA Centaur XPT System

  • Modelo / Serial
    All Serial Numbers; Software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656), V1.1 (Bundle 1.1.243 SMN 11221979, 11222064) and V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813).
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam.
  • Descripción del producto
    ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA